Long-term Safety of Spinal Cord Stimulation Systems in A Prospective, Global Registry of Patients With Chronic Pain

Abstract

Aim: The availability of long-term (>2 years) safety outcomes of spinal cord stimulation (SCS) remains limited. We evaluated safety in a global SCS registry for chronic pain. Methods: Participants were prospectively enrolled globally at 79 implanting centers and followed out to 3 years after device implantation. Results: Of 1881 participants enrolled, 1289 received a permanent SCS implant (1776 completed trial). The annualized rate of device explant was 3.5% (all causes), and 1.1% due to inadequate pain relief. Total incidence of device explantation >3 years was 7.6% (n = 98). Of these, 32 subjects (2.5%) indicated inadequate pain relief as cause for removal. Implant site infection (11 events) was the most common device-related serious adverse event (<1%). Conclusion: This prospective, global, real-world study demonstrates a high-level of safety for SCS with low rate of explant/serious adverse events. Clinical Trial Registration: NCT01719055 ( ClinicalTrials.gov )

Neuromodulation and Habituation: A Literature Review and Conceptional Analysis of Sustaining Therapeutic Efficacy and Mitigating Habituation

“…Interestingly, Rauck et al reported that 7.6% of a cohort of one thousand two hundred eighty-nine SCS subjects using custom and variable stim programming required an explant three years post-implantation, with only 2.5% of these subjects undergoing explanation due to inadequate pain relief [68]. This markedly lower incidence of overall explantation due to habituation compared to other studies could be partially explained by the induction of different cellular mechanisms of analgesia controlled by variable-stimulation programming [68]. Further, several studies have demonstrated that patients who had not maintained pain relief with conventional SCS therapy achieved pain improvement when their traditional SCS was replaced with HF-SCS [69][70][71].…”

Neuromodulation and Habituation: A Literature Review and Conceptional Analysis of Sustaining Therapeutic Efficacy and Mitigating Habituation

“…Interestingly, Rauck et al reported that 7.6% of a cohort of one thousand two-hundred eightynine SCS subjects using custom and variable stim programing required an explant three years post implantation with only 2.5% of these subjects undergoing explanation due to inadequate pain relief [67]. This markedly lower incidence of overall explantation due to habituation compared to other studies could be partially explained by induction of different cellular mechanisms of analgesia controlled by variable stim programming [67]. Further, several studies have demonstrated that patients who had not maintained pain relief with conventional SCS therapy achieved pain improvement when their traditional SCS was replaced with HF-SCS [68][69][70].…”

Design and Development of A web-based Chronic Pain Registry System

“…Pain registration systems with different goals and based on different methods have been designed and created in the world: web-based chronic pain registry systems with general goals, such as the first registration system in Sweden [4]. The pain registration system in Europe, Canada, Great Britain, America, and Norway [5][6][7][8] or web-bas registries with specific and limited goals that were created using existing applications, such as the registry of pain after knee and hip joint implantation in Spain or the pain registry of patients who underwent surgery in Germany [9][10][11][12].…”